Anesthesia Clinical Trial
Official title:
Comparison of the Effectiveness of Sedation With i.v. Dexmedetomidine in Combination With Midazolam Alone or Midazolam and Low Dose Ketamine for Extraction of Third Molars.
Intravenous sedation is used frequently for the relief of pain and anxiety associated with
oral surgical procedures performed under local anesthesia. The purpose of this study is to
learn about patient and surgeon satisfaction with sedation using Dexmedetomidine in
combination with midazolam alone or with midazolam plus low dose ketamine while having
wisdom teeth removed.
The sedation produced by dexmedetomidine is unique in that it mimics natural sleep, a unique
quality not shared by other drugs. Dexmedetomidine is often used in anesthesia in hospital
operating rooms and has been approved by the US Food and Drug Administration for the use
planned in this study.
Status | Terminated |
Enrollment | 18 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - American Society of Anesthesiology (ASA) physical status I and II - Four asymptomatic third molars indicated for removal Exclusion Criteria: - Clinical history or ECG evidence of: - cardiac dysrhythmia or heart block - ischemic heart disease - asthma - sleep apnea - impaired liver, renal, or mental function - chronic sedative or analgesic use - allergies to any of the study drugs - history of pericoronal infection with third molars |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina School of Dentistry | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Amnesia: Lack of Picture Recall Shown Prior to Sedation. | Subjects were shown pictures of familiar objects prior to sedation, after the bolus dose of dexmedetomidine was administered, at 15 minutes and 30 minutes into the surgery and at the end of surgery. Subjects were shown a page containing multiple pictures to evaluate whether they could remember any of them. No recall demonstrating the presence of amnesia during that portion of the procedure. This process was repeated the day following surgery | Day of surgery prior to discharge | No |
Primary | Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Prior to Sedation. | Lack of recall of picture shown indicates presence of amnesia the day following surgery. | One day after surgery | No |
Primary | Amnesia: Lack of Picture Recall Following Dexmedetomidine Infusion Plus Midazolam. | Percentage of patients unable to recall picture | Day of Surgery prior to discharge | No |
Primary | Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown Following Dexmedetomidine Infusion Plus Midazolam. | Inability to recall picture shown at this time indicates presence of amnesia on the day following surgery. | One day after surgery | No |
Primary | Amnesia: Lack of Picture Recall Shown 15 Minutes Into Surgery | Lack of recall of picture shown at this time indicates presence of amnesia | Day of Surgery prior to discharge | No |
Primary | Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 15 Minutes Into Surgery. | Lack of recall of picture demonstrates presence of amnesia on day following surgery | One day after surgery | No |
Primary | Amnesia: Lack of Picture Recall Shown 30 Minutes Into Surgery | Lack of recall of picture shown indicates presence of amnesia | Day of Surgery prior to discharge | No |
Primary | Primary Title: Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown 30 Minutes Into Surgery. | Lack of recall of picture shown indicates presence of amnesia on day following surgery. | One day after surgery | No |
Primary | Amnesia: Lack of Picture Recall at Surgery End Time. | Lack of recall of picture shown indicates presence of amnesia | Day of surgery prior to discharge | No |
Primary | Amnesia: Lack of Recall One Day After Surgery of The Picture That Was Shown at Surgery End Time. | Lack of recall of picture shown indicates presence of amnesia on day following surgery. | One day after surgery | No |
Secondary | Respiratory Parameters: Respiratory Rate | Respirations per minute | Immediately prior to sedation | Yes |
Secondary | Respiratory Parameters: Respiratory Rate | Rate of respirations | During surgical procedure | Yes |
Secondary | Respiratory Parameters: Oxyhemoglobin Saturation | Oxyhemoglobin saturation per pule oximeter | Immediately prior to surgery | Yes |
Secondary | Respiratory Parameters: Oxyhemoglobin Saturation | Oxyhemoglobin saturation per pulse oximetry | During surgical procedure | Yes |
Secondary | Respiratory Parameters: End-tidal Carbon Dioxide | Measured via capnography at nares | Immediately prior to sedation | Yes |
Secondary | Respiratory Parameters: End-tidal Carbon Dioxide | Measured by capnography at nares | Duration of surgery | Yes |
Secondary | Mean Arterial Blood Pressure | Blood pressure per automated monitor | Immediately prior to surgery | Yes |
Secondary | Mean Arterial Blood Pressure | Measured using automated blood pressure monitor | During duration of surgery | Yes |
Secondary | Heart Rate | Heart rate per EKG monitor | Prior to sedation | Yes |
Secondary | Heart Rate | Per EKG monitor | Duration of surgery | Yes |
Secondary | Surgeon Satisfaction With Sedation Technique | Numerical value on scale of 1-5 from Very dissatisfied (1) to Extremely satisfied (5) | After surgery completed: day of surgery, within 15 minutes | No |
Secondary | Patient Satisfaction With Sedation Technique | Rating of how satisfied the patient was with their sedation on a scale of 1-5 with 1 being very dissatisfied and 5 being extremely satisfied | after completion of surgery (within 15 minutes) | No |
Secondary | Ramsey Sedation Scale Score | Rating of depth of sedation by sedationist. Scale 1 - 6, 1 being widw awake and 6 being non-responsive | During surgical procedure | No |
Secondary | Bispectral Index Score (BIS) | Bispectral Index (BIS) measures level of consciousness by algorithmic analysis of the patient's electroencephalogram (EEG) during anesthesia and sedation. The BIS can range from 0 (equivalent to EEG silence) to 100 (equivalent to fully awake and alert). A BIS value of 40-60 indicates an adequate general anesthesia state. | During surgery duration. | No |
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